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Accepted manuscript

Evaluating the Safety Profile of Connectome-Based Repetitive Transcranial Magnetic Stimulation

Published online by Cambridge University Press:  21 March 2025

Si Jie Tang Open the ORCID record for Si Jie Tang [Opens in a new window] ,
Jonas Holle ,
Emil Gabrielsson ,
Nicholas B. Dadario ,
Mark Ryan ,
Maurice Sholas ,
Michael E. Sughrue ,
Charles Teo  and
Jacky Yeung
Si Jie Tang
Affiliation:
School of Medicine, 21772 University of California Davis Medical Center, Sacramento, CA USA
Jonas Holle
Affiliation:
Cingulum Health, Sydney, Australia
Emil Gabrielsson
Affiliation:
Cingulum Health, Sydney, Australia
Nicholas B. Dadario
Affiliation:
Robert Wood Johnson Medical School, Rutgers University, New Brunswick, New Jersey, USA
Mark Ryan
Affiliation:
Cingulum Health, Sydney, Australia
Maurice Sholas
Affiliation:
Sholas Medical Consulting, LLC, New Orleans, LA
Michael E. Sughrue
Affiliation:
Cingulum Health, Sydney, Australia
Charles Teo
Affiliation:
Cingulum Health, Sydney, Australia
Jacky Yeung*
Affiliation:
Department of Neurosurgery, Yale University School of Medicine PO Box 208082, New Haven, CT, 06520, USA
*
Corresponding author: Jacky Yeung, MD, P.O. Box 208082, New Haven, CT 06520-8082, Tel: 203.785.2805, Fax: 203.785.6916, Email: [email protected]
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Abstract

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Objective:

New developments in neuro-navigation and machine learning have allowed for personalized approaches to repetitive transcranial magnetic stimulation (rTMS) to treat various neuropsychiatric disorders. One specific approach, known as the Cingulum Framework, identifies individualized brain parcellations from resting state fMRI based on a machine-learning algorithm. Theta burst stimulation, a more rapid form of rTMS, is then delivered for 25 sessions, 5 per day, over 5 days consecutively or spaced out over 10 days. Preliminary studies have documented this approach for various neurological and psychiatric ailments. However, the safety and tolerability of this approach is unclear.

Methods:

We performed a retrospective study on 165 unique patients (202 Target Sets) treated with this personalized approach between January 2020 to December 2023.

Results:

Common side effects included fatigue (102/202, 50%), local muscle twitching (89/202, 43%), headaches (49/202, 23%), and discomfort (31/202, 17%), all transient. The top 10 unique parcellations commonly found in the Target Sets included L8av (52%), LPGs (28%), LTe1m (21%), RTe1m (18%), LPFM (17%), Ls6-8 (13%), Rs6-8 (9%), L46 (7%), L1 (6%), and L6v (6%). Fatigue was most common in Target Sets that contained R6v (6/6, 100%) and L8c (5/5, 100%). Muscle twitches were most common in Target Sets that contained RTGv (5/5, 100%) and LTGv (4/4, 100%).

Conclusion:

These side effects were all transient and well-tolerated. No serious side effects were recorded. Results suggested that individualized, connectome-guided rTMS is safe and contain side effect profiles similar to other TMS approaches reported in the literature.

Keywords

TBSrTMSconnectomesafetyHuman Connectome Project
Type
Original Article
Information
Acta Neuropsychiatrica , Accepted manuscript , pp. 1 - 32
Creative Commons
Creative Common License - CCCreative Common License - BY
This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution and reproduction, provided the original article is properly cited.
Copyright
© The Author(s), 2025. Published by Cambridge University Press on behalf of Scandinavian College of Neuropsychopharmacology